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Published by: Espicom Healthcare Intelligence
Published: Jun. 11, 2012 - 100 Pages
Table of Contents- FOREWORD
- EXECUTIVE SUMMARY
- RESPIRATORY DRUGS MARKET
- Market Leaders
- Generics
- Challenges for Generic Developers
- Critical Path Opportunities for Generic Drugs in the US
- ASTHMA & COPD
- Market Overview
- Asthma
- COPD
- Inhalation Drug Delivery Background
- Market Leaders
- Generic Competition
- Flixotide/Flovent (fluticasone propionate)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Seretide/Advair (fluticasone propionate+ salmeterol xinafoate)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Mylan
- Sandoz
- Cipla
- Market Outlook
- Serevent (salmeterol xinafoate)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Ventolin (salbutamol [albuterol])
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Foradil (formoterol fumarate)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Pulmicort (budesonide)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Teva
- Apotex
- Sandoz
- Watson
- Market Outlook
- Symbicort (budesonide+formoterol)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Xopenex (levalbuterol)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Mylan
- Watson
- Teva
- Market Outlook
- Asmanex Twisthaler (mometasone furoate)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Alvesco (ciclesonide)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Combivent (ipratropium bromide + salbutamol [albuterol])
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Spiriva (tiotropium bromide)
- Mode of Action
- Approvals
- Lifecycle Development
- Patents
- Generic Company Activity
- Market Outlook
- Brovana (arformoterol tartrate)
- Mode of Action
- Approvals
- Patents
- Patent Infringement Litigation
- Generic Company Activity
- Market Outlook
- Onbrez Breezhaler/Arcapta Neohaler (indacaterol)
- Mode of Action
- Approvals
- Patents
- Market Outlook
- ALLERGIC RHINITIS
- Market Overview
- Market Leaders
- New Products to Watch
- In Development
- Approved Generics
- Nasonex (mometasone furoate)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Flixonase/Flonase (fluticasone propionate)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Avamys/Veramyst (fluticasone furoate)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Rhinocort (budesonide)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Nasacort (triamcinolone acetonide)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Astelin/Astepro (azelastine hydrochloride)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- Omnaris (ciclesonide)
- Mode of Action
- Approvals
- Patents
- Generic Company Activity
- Market Outlook
- GENERIC COMPETITORS
- Apotex
- Respiratory Market Presence
- Azelastine Hydrochloride
- Pulmicort Respules (budesonide) Litigation
- Cipla
- Respiratory Market Presence
- Mylan
- Respiratory Market Presence
- Perforomist (formoterol fumarate)
- Levalbuterol
- Acquisition of Respiratory Delivery Platform
- Nephron Pharmaceuticals
- Respiratory Market Presence
- Sandoz
- Respiratory Market Presence
- In Development
- Veramyst (fluticasone furoate) Litigation
- Pulmicort Respules (budesonide) Litigation
- Teva Pharmaceuticals Industries
- Respiratory Market Presence
- Proair (albutero])
- Qvar (beclomethasone dipropionate
- Neovent/Sereflo (salmeterol xinafoate)
- Generics
- Xopenex litigation settlement
- Watson
- Respiratory Market Presence
- Pulmicort Respules (budesonide) Litigation
- Sources
- Index
- List of Tables
- FDA ANDA Approvals, 2005-2012
- Sales of Leading Inhalable Asthma/COPD Drugs, 2010-2011 (US$ Million)
- US Patent Expiry of Leading Inhalable Asthma/COPD Drugs
- FDA ANDA Approvals for Asthma/COPD Inhalable Drugs, 2002-2012
- Flovent HFA US Patents
- Flovent Diskus US Patents
- Flixotide/Flovent Sales, 2008-2017 (£ & US$ Million)
- Advair HFA US Patents
- Advair Diskus US Patent
- Seretide/Advair Sales, 2008-2017 (£ & US$ Million)
- Serevent US Patents
- Serevent Sales, 2008-2017 (£ & US$ Million)
- Ventolin HFA US Patents
- Ventolin Sales, 2009-2017 (£ & US$ Million)
- Foradil US Patents
- Foradil Sales, 2008-2017 (US$ Million)
- Pulmicort Flexhaler US Patents
- Pulmicort Respules US Patents
- Pulmicort Sales, 2008-2017 (US$ Million)
- Symbicort US Patents
- Symbicort Sales, 2008-2017 (US$ Million)
- Xopenex US Patents
- FDA ANDA Approvals for Levalbuterol Inhalation Solution
- Tentative ANDA Approvals for Levalbuterol Inhalation Solution
- Xopenex Sales, 2008-2017 (¥ Billion & US$ Million)
- Asmanex Twisthaler US Patents
- Asmanex Twisthaler Sales, 2008-2017 (US$ Million)
- Alvesco US Patents
- Alvesco Sales, 2008-2017 (US$ Million)
- Combivent US Patent
- Combivent Respimat US Patents
- Combivent Sales, 2008-2017 (US$ Million)
- Spiriva US Patents
- Spiriva Sales, 2008-2017 (US$ Million)
- Brovana Neohaler US Patents
- Brovana Sales, 2008-2017 (US$ Million)
- Arcapta Neohaler US Patents
- Onbrez Breezhaler/Arcapt Neohaler Sales, 2010-2017 (US$ Million)
- Sales of Leading Nasal Spray Allergy Drugs, 2010-2011 (US$ Million)
- US Patent Expiry for Leading Nasal Spray Allergy Drugs
- FDA ANDA Approvals for Allergy Nasal Sprays, 2002-2012
- Nasonex US Patents
- Nasonex Sales, 2008-2017 (US$ Million)
- FDA ANDA Approvals for Fluticasone Propionate Nasal Spray
- Flixonase/Flonase Sales, 2008-2017 (£ & US$ Million)
- Veramyst US Patents
- Avamys/Veramyst Sales, 2008-2017 (£ & US$ Million)
- Product US Patents
- Rhinocort Sales, 2008-2017 (US$ Million)
- Nasacort US Patents
- Nasacort Sales, 2008-2017 (US$ Million)
- Astepro US Patents
- Astelin/Astepro Sales, 2008-2017 (SEK & US$ Million)
- Omnaris US Patents
- Omnaris Sales, 2008-2017 (EUR & US$ Million)
- Nephron Pharmaceuticals ANDA Approvals, 2001-2009
- Teva ANDA Approvals, 2007-2009
- Watson ANDA Approvals for, 2007-2008
- List of Figures
- Leading Respiratory Products by Mode of Delivery, 2011 (%)
- Respiratory Market Share by Company, 2011 (%)
- Flixotide/Flovent Sales, 2008-2017 (US$ Million)
- Seretide/Advair Sales, 2008-2017 (US$ Million)
- Serevent Sales, 2008-2017 (US$ Million)
- Ventolin Sales, 2009-2017 (US$ Million)
- Foradil Sales, 2008-2017 (US$ Million)
- Pulmicort Sales, 2008-2017 (US$ Million)
- Symbicort Sales, 2008-2017 (US$ Million)
- Xopenex Sales, 2008-2017 (US$ Million)
- Asmanex Twisthaler Sales, 2008-2017 (US$ Million)
- Alvesco Sales, 2008-2017 (US$ Million)
- Combivent Sales, 2008-2017 (US$ Million)
AbstractIt is no surprise then, that such high revenue originator drugs are attracting interest from prospective generic competitors. Unlike the oral generics market, however, where numerous companies typically compete for a revenue share, relatively few companies have the technology and expertise to compete in the market for generic inhalation and nasal spray products. But for those that are successful, there are significant revenue opportunities.
Overcoming the delivery challenge
While it is possible for companies to develop bioequivalent generic versions of nasal spray products, significant barriers remain to gaining entry into the more lucrative asthma/COPD market. The few generic inhalable products currently approved by the FDA in this therapy area are solutions, generally for delivery via a nebuliser. This is partly due to developments in the delivery devices, following the phasing out of CFCs in metered dose inhalers (MDIs) in favour of devices that use the more ozone friendly hydrofluoroalkane (HFA).
Developing a hand-held generic inhaler is no easy task. The bioavailability of the drug in the airway relies on a combination of the drug and the delivery device. To date, companies have been unable to gain marketing approval for bioequivalent generics in the US via the ANDA route. Some generics have been approved in the EU, but these are generally branded products that use proprietary inhalation devices and are, therefore, not pure generics and unlikely to be interchangeable at the pharmacy.
Key questions answered:
What delivery solutions have been found?
Which are the products to watch?
Who’s making the running in this sector?
The answer to these and thousands of other key business questions can be found in this new market research study from Espicom. Essential reading for pharma executives, those in the generic field and the commercial community, this 128-page fact-filled report provides a complete and comprehensive review of the issues, trends, products and companies that are shaping the global market in this sector.
Development of generic alternatives in this sector will require some inspired thinking. Maybe not a generic approach at all?
Patent issues
The generic market is undergoing radical restructuring, with much rationalisation of the corporate landscape. In such a competitive environment, companies are now seeking not just new opportunities, but opportunities which combine good profit levels and a degree of product novelty ? both of which are available in the inhalation and nasal spray market.
Side stepping the bioequivalence problem
A few companies have avoided this problem by gaining approval for branded products that use proprietary inhalation devices. Among these are Teva, which has two successful branded asthma inhalers, Proair (salbutamol) and Qvar (beclomethasone dipropionate); and Orion, with its Easyhaler DPI. In October 2011, Teva became the first company to launch a generic salmeterol xinafoate 25mcg pMDI in the UK, following approval by the MHRA in April 2011. The UK marketing authorisation holder for the product, which is branded Neovent/Sereflo, is Neolab Ltd, a UK-based pharmaceutical development company. GSK has been quick to point out that Neovent is a branded product that is not identical to Serevent and, therefore, not an interchangeable generic. This is clearly Teva’s approach: its beclomethasone dipropionate HFA nasal aerosol for the treatment of SAR will not be a generic and an NDA was submitted in May 2011 to the FDA.
Gearing up for Seretide/Advair?
Undoubtedly the biggest prize for generic manufacturers will be the current market leader: GSK’s Seretide/Advair, which achieved revenue of US$8,247 million in 2011 – nearly twice the value of its nearest competitor. GSK has US patents for Advair with expiry dates up to July 2025, although the combination patent expired in 2010. In Europe the UK patent has been revoked, but Seretide is protected by Supplementary Protection Certification in other countries until 2013.
At least two generic versions of Seretide/Advair are currently in development. Sandoz and Vectura are jointly developing VR315, a combination product that is widely thought to be generic Seretide/Advair. Sandoz currently has development and commercialisation rights in Europe and other markets, excluding the US. Vectura licensed the US rights to this product to an undisclosed pharmaceutical company in August 2011. Mylan is developing a generic fluticasone+salmeterol combination product, utilising Pfizer’s dry powder inhaler delivery platform, following an agreement between the companies in 2011. Mylan is targeting a launch of its generic in Europe in 2015, followed by the US in 2016.
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